Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral Liquid

NCT03413358 | Unknown

• 1 other identifier: 2017-133-KY-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of Sheng Bai oral liquid in prevention and treatment of the decrease of neutrophilics after chemotherapy in patients with non-small-cell lung cancer.

Conditions

Non-small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• The incidence and degree of neutropenia after chemotherapy

  Comparison of the incidence and extent of neutrophil reduction in two chemotherapy cycles between two groupschemotherapy cycles between two groups according to CTC AE4.03,as well as the recovery time of neutropenia

  six weeks

• The recovery time of neutropenia

  Comparison of the recovery time between two groups of Polymorphonuclear neutropenia

  six weeks

Secondary Outcomes (13)

• The incidence of neutropenia associated with Fever (FN) in patients after chemotherapy

  six weeks

• The incidence of Peripheral blood thrombocytopenia disease

  six weeks

• The duration of Peripheral blood thrombocytopenia disease

  six weeks

• THE incidence and duration of hemoglobin reduction in peripheral blood

  six weeks

• THE duration of hemoglobin reduction in peripheral blood

  six weeks

Other Outcomes (1)

• Genetic Testing

  six weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.

Drug: Sheng Bai oral liquid; Drug: Platinum-based two medicine (carboplatin / cisplatin) .

Control group

EXPERIMENTAL

Blank control and Platinum-based two medicine (carboplatin / cisplatin) .

Drug: Platinum-based two medicine (carboplatin / cisplatin) .

Interventions

Sheng Bai oral liquid DRUG

Drug: Sheng Bai oral liquid 40 mL, oral use, thrice daily after screening on the same day in the second course of the chemotherapy. Subjects will be treated for 2 courses

Treatment group

Platinum-based two medicine (carboplatin / cisplatin) . DRUG

Using Platinum-based two medicine (carboplatin / cisplatin)

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are confirmed no small cell lung cancer in accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination which investigators think are suitable to accept The platinum-based doublet chemotherapy（According to RECIST V1.1,patients with no small cell cancers should have one measurable lesions at least ）.
• ECOG performance status ≤2.
• Laboratory inspection basically meets the following requirements： 1)Blood test：a. WBC≥ 4.0×109/L, b. ANC≥2.0×109/L, c. PLT≥100×109/L. 2)Biochemical test：a. ALT≤2.5 times the ULN;b. AST≤2.5 times the ULN ;c. Cr\<=1.5 times the ULN.
• Expected survival period is more than 3 months
• Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

You may not qualify if:

• Patients need radiotherapy, targeted therapy, and other anti-cancer therapies during the trial.
• Patients accepted radiation in the past 4 weeks before enrollment.
• Previous bone marrow or stem cell transplant, or organ allograft.
• Recently severe acute infection is not controlled; purulent or chronic infection is present and the wound is not healed.
• Patients were or being suspected to be allergic to test drugs or related components.
• Patients with hypersplenism, hyperthyroidism, adrenal cortical hypofunction, connective tissue disease, infectious diseases, such as viral hepatitis, tuberculosis infection and other diseases which can lead to the decrease of the white blood cells at the same time.
• Patients with the symptoms of digestive system, such as nausea, vomiting, diarrhea, etc., that are not controlled will influence the test drug.
• The central nervous system is metastatic and has symptoms.
• History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma.
• Patients with severe heart, liver and kidney diseases; serious diseases of hematopoietic system; bleeding tendency.
• Patients have a history of drug abuse and cannot be reined ;Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder have less compliance.
• Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception.
• Patients who are currently included in other clinical trials or accepted any experimental drugs in the past 4 weeks.
• Any condition, in the investigator's opinion, is not in the best interest of the subject.

Sponsors & Collaborators

• BeiJing Yijiayi Medicine Techonoloy Co., Ltd.: lead
• Hubei Mon Yan Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Links

• Standards for the diagnosis and treatment of primary lung cancer (2015 version) in China
• NCCN Guidelines® : China Editions

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hongsheng Lin, Professor

  CHINA ACADENY OF CHINESE MEDICAL SCIENCES Guang'anmen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongsheng Lin, Professor

CONTACT

010-88001192; drlinhongsheng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: These subjects will be randomized (1:1) to treatment group or control group.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 29, 2018
• Study Start: January 15, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

CN (1)